Structural Endpoints and Outcome Measures in Uveitis

Abstract

Most uveitis entities are rare diseases but, taken together, are responsible for 5–10% of worldwide visual impairment which largely affects persons of working age. As with many rare diseases, there is a lack of high-level evidence regarding its clinical management, partly due to a dearth of reliable and objective quantitative endpoints for clinical trials. This review provides an overview of available structural outcome measures for uveitis disease activity and damage in an anatomical order from the anterior to the posterior segment of the eye. While there is a multitude of available structural outcome measures, not all might qualify as endpoints for clinical uveitis trials, and thorough testing of applicability is warranted. Furthermore, a consensus on endpoint definition, standardization, and “core outcomes” is required. As stipulated by regulatory agencies, endpoints should be precisely defined, clinically important, internally consistent, reliable, responsive to treatment, and relevant for the respective subtype of uveitis. Out of all modalities used for assessment of the reviewed structural outcome measures, optical coherence tomography, color fundus photography, fundus autofluorescence, and fluorescein/indocyanine green angiography represent current “core modalities” for reliable and objective quantification of uveitis outcome measures, based on their practical availability and the evidence provided so far.

Successful treatment of cytomegalovirus retinitis with oral/intravitreal antivirals in HIV-negative patients with lymphoma

“…In this regard, in the analysis visual acuity was not considered as criteria for treatment response, since this important clinical variable could be particularly insensitive in patients with posterior uveitis in which chorioretinal lesions may cause structural irreversible damage [32][33][34]. Importantly, there is a need for PCR confirmation of the viral DNA, since retinitis lesions in this subset of patients may look different from that seen in HIV patients, due to the presence of more inflammatory findings, so can mimic alternatives diagnoses, in particular acute retinal necrosis.…”

Spectrally resolved autofluorescence imaging in posterior uveitis

“…Inflammatory activity was defined on an eye-level in birdshot chorioretinopathy and ocular sarcoidosis and on a lesion-level in APMPPE, PIC, Toxoplasmosis chorioretinitis, MCP, POHS, and serpiginous choroiditis (inflammatory activity grading available in Supplementary Table S1) [15][16][17][18][19][20][21][22][23] . In general, the synopsis of all clinical findings was determinant for the definition of inflammatory activity.…”

Measuring Inflammation in the Vitreous and Retina: A Narrative Review

“…Inflammation can manifest posteriorly as macular oedema, choroidal and/or retinal infiltrates, retinal vasculitis and optic nerve changes. 11,42 With the exception of macular oedema (where quantification with OCT is well-established) the measurement of these changes is challenging in both routine practice and clinical trial settings.…”